FDA 510(k) Application Details - K232436

Device Classification Name	More FDA Info for this Device
510(K) Number	K232436
Device Name	Rapid SDH
Applicant	iSchemaView, Inc. 1120 Washington Ave. Suite 200 Golden, CO 80401 US Other 510(k) Applications for this Company
Contact	Jim Rosa Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2023
Decision Date	10/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review